[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extremity-injuries-lower\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extremity-injuries-lower":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":34,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100617117","procedural-sedation-and-analgesia-for-treatment-of-adults-with-fractures-and-dislocations-in-the-emergency-department-100617117",false,"NCT07314450","Procedural Sedation and Analgesia for Treatment of Adults With Fractures and Dislocations in the Emergency Department","PAINEX","Inclusion Criteria:\n\n1. Age ≥18.\n2. Patients with the following injuries are eligible:\n\n   1. Reduction treatment of shoulder dislocation\n   2. Reduction treatment of elbow dislocation\n   3. Reduction treatment of distal radius fractures, application of cast\n   4. Reduction treatment of finger fractures\u002Fdislocation\n   5. Casting treatment of upper extremity fractures\n\n      * Proximal humerus fracture, application of fixed sling\n      * Humeral shaft fracture, application of Sarmiento brace\n      * Supracondylar fracture, application of angled cast\n   6. Reduction treatment of hip dislocation\n   7. Reduction treatment of patella dislocation\n   8. Reduction of tibial shaft fracture, application of cast\n   9. Reduction treatment of ankle fractures including distal tibia fracture\n   10. Reduction treatment for toe fractures\u002Fdislocation\n   11. Casting treatment of lower extremity fractures\n\n       * Distal femur fracture, application of cast\u002Ftraction\n       * Proximal tibia fracture, application of cast or hinged brace\n       * Ankle fracture, application of walker\n\nExclusion Criteria:\n\n1. Unable to give informed consent (e.g. unconscious, psychotic or dementia)\n2. Unwilling to participate in the study\n3. Prior inclusion in the study\n4. Already included in another clinical study at the same day\u002Fhospital visit\n5. Pregnant or breastfeeding","ALL","18 Years",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the effectiveness and safety of different procedural sedation and analgesia methods used for adults with painful fractures requiring reduction treatment in the emergency department.\n\nThe main questions it aims to answer are:\n\n* Which sedation and analgesia methods provide the best patient satisfaction and pain relief?\n* How do different treatment methods affect clinician satisfaction and the occurrence of adverse events?\n\nThe investigators will compare different types of procedural sedative and analgesic treatments (such as systemic sedation\u002Fanalgesia and regional techniques like nerve or hematoma blocks) to see which approach offers the best patient satisfaction and most effective pain control.\n\nParticipants will:\n\nBe adult patients with upper or lower extremity fractures or joint dislocations requiring painful reduction procedures.\n\nReceive one of the routinely used sedation or analgesia treatments (or no analgesia) during their emergency department care.\n\nReport their pain levels and satisfaction before, during, and after treatment. Be monitored for any side effects, complications, or use of antidotes. Data will be collected over a six-month period at Odense University Hospital, Holbæk Hospital, and Zealand University Hospital, Køge, following the STROBE guidelines for observational studies.",[24,25,26,27,28,29,30,31,32,33],"Pain, Procedural","Analgesia","Extremity Injury","Patient Satisfaction","Satisfaction, Personal","Satisfaction","Upper Extremity Injury","Lower Extremity Fracture","Upper Extremity Fracture","Extremity Injuries Lower",[35,36],"Emergency Department","Procedural sedation and analgesia","RECRUITING","2025-12-17",{"date":40,"type":41},"2026-01-02","ACTUAL",{"date":43,"type":41},"2025-07-29",{"date":45,"type":20},"2026-07-01",{"name":47,"class":48},"Region Zealand","OTHER",3,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100538640","accelerated-flap-coverage-in-severe-lower-extremity-trauma-100538640","NCT06293469","Accelerated Flap Coverage in Severe Lower Extremity Trauma","Accelerated Flap Coverage Versus Standard Timing in the Treatment of Severe Lower Extremity Musculoskeletal Injuries","FLAP ATTACK","The inclusion criteria are:\n\n1. Patients 18 years of age or older.\n2. Severe lower extremity open fracture and\u002For dislocation below the knee requiring an acute flap for management of the musculoskeletal injury.\n3. Will have all planned flap surgeries performed by a participating surgeon or delegate.\n4. Able to be randomized within 48 hours of injury.\n\nThe exclusion criteria are:\n\n1. Site is unable to implement the accelerated flap protocol due to local logistics.\n2. Primary amputation anticipated prior to attempted flap for management of the injury.\n3. Critical limb ischemia that requires re-vascularization for limb perfusion.\n4. Chronic or acute infection at or near the musculoskeletal injury site at the time of initial injury surgery.\n5. Burns at the musculoskeletal injury site.\n6. Incarceration.\n7. Expected injury survival of less than 12 months.\n8. Terminal illness with expected survival of less than 12 months.\n9. Currently enrolled in a trial that does not permit co-enrollment.\n10. Declined to provide informed consent.\n11. Unable to obtain informed consent due to language barriers.\n12. Unable to obtain informed consent because a legally authorized representative was unavailable.\n13. Anticipated problems, in the judgment of research personnel, with maintaining follow-up with the patient.\n14. Prior enrollment in the trial.\n15. Eligible patient or LAR was not approached within screening window (missed participant).\n16. Other reason to exclude the patient, as approved by the Principal Investigators.",{"count":59,"type":20},356,"INTERVENTIONAL",[62],"NA","The goal of this randomized controlled trial is to determine if accelerated flap coverage compared to standard flap coverage timing leads to improved infection-related complications in patients with open fractures and\u002For dislocations below the knee. Eligible patients will be randomized to receive either a flap within a goal of 72 hours of injury or standard of care flap timing for the institution. The primary outcome will be a composite outcome to evaluate clinical status 6 months after randomization. Components of the composite outcome will be hierarchically assessed in the following order: 1) all-cause mortality, 2) amputation related to injury, 3) re-operation for infection and\u002For flap complication (flap compromise, partial and\u002For complete flap failure), and 4) days in hospital, defined as days in an acute in-patient hospital (i.e., not rehab or nursing facility).",[65,66,67,33],"Open Tibia Fracture","Open Dislocation of Ankle","Extremity Fracture Lower","2025-10-10",{"date":70,"type":41},"2025-10-14",{"date":72,"type":41},"2024-11-04",{"date":74,"type":20},"2030-02",{"name":76,"class":48},"Johns Hopkins University",9]